Report of the Clinical Protocol Committee: Development of Randomized Trials for Malignant Bowel Obstruction

Thomas Anthony, Todd Baron, Sebastiano Mercadante, Sylvan Green, Dennis Chi, John Cunningham, Anne Herbst, Elizabeth Smart, Robert S. Krouse

Research output: Contribution to journalArticlepeer-review

118 Scopus citations


Malignant bowel obstruction (MBO) is a commonly encountered palliative care problem. There have been very few comparative trials in this area, and consequently there is very little clinical evidence upon which therapy can be rationally based. The purpose of this paper is to highlight the discussion and decision-making process that was undertaken by the Clinical Protocol Subcommittee during the development of a proposed clinical trial of best medical care versus surgical or endoscopic treatment for MBO. The development of the proposed clinical trials followed an orderly process. The first step taken was a discussion of a specific definition for MBO. Once agreed upon, this definition helped identify inclusion and exclusion criteria for the proposed trial. This was followed by an extensive literature review, which helped define both surgical and endoscopic approaches to MBO as well as what constituted best medical care. An extensive discussion was then undertaken concerning the best outcome measure of success for medical, surgical, and endoscopic interventions. All of the above steps culminated in two proposed protocols, one for MBO of the small intestine distal to the ligament of Treitz and a second for colonic obstructions. The small intestinal trial is designed to compare surgical intervention versus best medical care, whereas the colonic trial seeks to compare surgery with endoscopically-placed intraluminal stents coupled with best medical care.

Original languageEnglish (US)
Pages (from-to)S49-S59
JournalJournal of Pain and Symptom Management
Issue number1 SUPPL.
StatePublished - Jul 2007


  • Malignancy
  • bowel obstruction
  • clinical trial

ASJC Scopus subject areas

  • General Nursing
  • Clinical Neurology
  • Anesthesiology and Pain Medicine


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